Gilead: Stop Blocking PrEP

ACT UP Dublin has renewed the call for pharma giant Gilead Sciences to stop blocking access to its anti-HIV medication, Truvada. ACT UP demands that Gilead end its efforts to extend its expired patent and significantly drop the price where the patent is still in effect.

Members of ACT UP Dublin gathered outside the High Court in Dublin this morning as Gilead’s legal team arrived for the first day of a trial on the validity of the Supplementary Protection Certificate (SPC) for Truvada. The original patent expired in 2017, but the disputed SPC would extend Gilead’s monopoly on Truvada until 2020 in Ireland.

“A victory in this suit might bring a windfall for Gilead, but it would be a disaster for Ireland’s HIV prevention efforts,” Leavitt warned.

While it is widely anticipated that the Irish court will find the SPC invalid, a ruling in Gilead’s favour could upend plans for provision of PrEP by the State. A draft Health Technology Assessment report from HIQA found that PrEP is safe and highly effective, and—based on the lower prices charged by generic companies—that a PrEP programme would be cost saving for Ireland, noting that “providing PrEP is less costly… than not providing PrEP.”

Scheduled to run for three weeks, the trial is the latest round in a dispute which began in July 2017. In November 2017 the court denied an injunction sought by Gilead to prevent the sale of generic versions of Truvada in Irish pharmacies prior to a ruling on the validity of the SPC.

Truvada—a combination of anti-HIV drugs tenofovir and emtricitabine—is widely used in combination with additional drugs in the treatment of HIV. It is also the only medication approved for use in the prevention method known as pre-exposure prophylaxis (PrEP).

Two generic versions of Truvada—marketed by Mylan and Teva, the defendants in the current litigation—are currently available in Irish community pharmacies, retailing for as little as €50 for a month’s supply. Before the launch of generics in December 2017, PrEP users in Ireland would have had to pay over €400 per month for branded Truvada.

The Irish case goes to trial as Gilead Sciences faces increasing criticism around patent claims for Truvada in the United States. Since last year a coalition of activists has called on the US National Institutes of Health to break Gilead’s patent on Truvada in the US to allow generic manufacturers to enter the market there.

Following revelations in March of unenforced patents held by the US Centers for Disease Control on the use of Truvada as PrEP, US activists have called for the CDC to enforce the patents or use them as leverage to force Gilead to drop the exorbitant price it charges for Truvada in the US.

A group of US senators has also called on the Dept. of Health and Human Services to enforce its patents, decrying multinational companies who reap “billions of dollars in profits without properly compensating the government for its investments.” And last week it was reported that the US Justice Department is reviewing the unenforced CDC patents.

ACT UP Dublin member Andrew Leavitt said, “Gilead’s behaviour has been disgraceful. The high price Gilead demands for Truvada has delayed PrEP access across Europe—including here in Ireland—and continues to be a huge obstacle to access in the US. This is not how a responsible, community-minded company—especially one supposedly concerned about health—should act.”